The safety of indacaterol for the treatment of COPD

Metaxas, Evgenios; Balis, Evangelos

doi:10.1080/14740338.2018.1472233

Cited by 8 publications

(9 citation statements)

References 51 publications

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“…One patient experienced a serious ADR (COPD exacerbation), which resulted in treatment discontinuation. Earlier clinical studies have also reported that a notable proportion of patients receiving indacaterol experience a short-lasting cough a few seconds after inhalation ( 18 ). A subgroup analysis of ADRs by age category showed the tolerability of indacaterol in all age groups.…”

Section: Discussionmentioning

confidence: 95%

“…Furthermore, some studies have reported that LABAs have the potential to increase the heart rate and can induce some class-related side effects, including palpitations, tremors, muscle spasm, and prolongation of the QTc interval ( 1 , 18 ). However, limited evidence is available concerning the safety and efficacy of indacaterol maleate in a real-life setting in Japan.…”

Section: Introductionmentioning

confidence: 99%

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Real-world Safety and Efficacy of Indacaterol Maleate in Patients with Chronic Obstructive Pulmonary Disease: Evidence from the Long-term Post-marketing Surveillance in Japan

et al. 2021

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Objective Evidence concerning the safety and efficacy of indacaterol maleate in a real-life setting is limited. The objective of this post-marketing surveillance was to evaluate the real-life safety and efficacy of indacaterol maleate in Japanese patients with chronic obstructive pulmonary disease (COPD). Methods This was a 52-week post-marketing surveillance conducted between April 2012 and December 2018. The safety endpoints included the incidence of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs). The efficacy endpoints included the physician-reported global evaluation of treatment effectiveness (GETE), change from baseline in the COPD assessment test (CAT) results, forced vital capacity (FVC), forced expiratory volume in 1 second (FEV 1 ), and %FEV 1 following 4, 12, 26, and 52 weeks of indacaterol administration. Results Of the 1,846 enrolled patients, 1,726 were included in the safety and efficacy analyses. The mean age of the patients was 72.5 years old. Cough, pneumonia and COPD worsening were the most common AEs reported, while pneumonia (1.04%) was the most common SAE, and cough (1.68%) was the most common ADR. GETE showed that 69.70% of patients achieved an excellent/good/moderate response following indacaterol treatment. The CAT score decreased, and lung function parameters (FVC, FEV 1 and %FEV 1 ) improved across all the COPD stages following treatment with indacaterol. Conclusion Indacaterol showed a favorable safety and tolerability profile in Japanese patients with COPD without new safety signals observed in real-life settings. These findings demonstrated that indacaterol is an effective maintenance treatment in real-life practice for Japanese patients with COPD.

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Section: Discussionmentioning

confidence: 95%

Section: Introductionmentioning

confidence: 99%

Real-world Safety and Efficacy of Indacaterol Maleate in Patients with Chronic Obstructive Pulmonary Disease: Evidence from the Long-term Post-marketing Surveillance in Japan

et al. 2021

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“…Indacaterol and glycopyrronium belong to the latest generation of beta-2 agonists and muscarinic antagonists, respectively, to be used as bronchodilators in patients with COPD. A large number of trials have demonstrated, as summarized in review articles, the efficacy and safety of indacaterol,1–4 glycopyrronium,5–8 and the combination of the two drugs 9–12. This scientific evidence was highlighted by meta-analyses, resulting in comparable efficacy and safety of both bronchodilators.…”

Section: Introductionmentioning

confidence: 99%

Patient-reported outcomes and considerations in the management of COPD: focus on indacaterol/glycopyrronium bromide

Ridolo¹,

Pellicelli²,

Gritti³

et al. 2019

PPA

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Dual bronchodilation with long-acting beta-2 agonists and muscarinic antagonists is recommended in patients with severe to very severe COPD. Among dual bronchodilator combinations, indacaterol/glycopyrronium combination (IGC) received evidence of higher efficacy and good safety compared with monotherapy with either drug as well as with tiotropium. In randomized controlled trials, the primary outcome is usually the change in mean FEV1 resulting from treatment. However, the functional aspects that influence the physician’s choice of the type of management may not be considered important by the patient, based on his perception of the disease. To address such issue, patient-reported outcomes (PROs) were assessed in recent studies. They include patient’s perception of breathlessness, physical functioning, global health status, quality of life, use of rescue medications, and patient’s report of COPD exacerbations. PRO data from the studies showed a clear improvement in patients’ awareness of a better control of the disease in patients treated with IGC. In addition, the latest literature on two important issues influencing patient’s preference and adherence, ie, the once-daily administration and the device to be used, confirmed the effectiveness of IGC and the ability of its device (Breezhaler®) to result in patient’s satisfaction, ease of use, less handling errors, and self-assurance to have inhaled the entire dose.

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“…In 2013, the combination therapy of indacaterol maleate and the LAMA glycopyrronium was approved in the EU and Japan as an once-daily dual bronchodilator therapy in COPD (Ultibro® Breezhaler® [ 4 , 5 ]). Indacaterol maleate shows a rapid onset of action within minutes of administration and provides 24 h bronchodilation in patients with COPD [ 6 ]. Since its approval, the efficacy and safety of indacaterol in patients with COPD has been established through numerous randomised controlled trials and real-world evidence studies [ 6 – 9 ].…”

Section: Introductionmentioning

confidence: 99%

“…Indacaterol maleate shows a rapid onset of action within minutes of administration and provides 24 h bronchodilation in patients with COPD [ 6 ]. Since its approval, the efficacy and safety of indacaterol in patients with COPD has been established through numerous randomised controlled trials and real-world evidence studies [ 6 – 9 ].…”

Section: Introductionmentioning

confidence: 99%

Lung function, pharmacokinetics, and tolerability of inhaled indacaterol maleate and acetate in asthma patients

et al. 2020

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Background Indacaterol maleate delivered with the Breezhaler® inhalation device is a long-acting β2-agonist approved for chronic obstructive pulmonary disease. In the development of a once daily, inhaled fixed dose combination (FDC) of indacaterol, glycopyrronium bromide (a long-acting muscarinic antagonist), and mometasone furoate (an inhaled corticosteroid [ICS]) for the treatment of patients with asthma, the acetate salt of indacaterol is used instead of the maleate salt. Here, we investigated the lung function, pharmacokinetics (PK) and safety of indacaterol maleate 150 μg once daily (o.d.) and indacaterol acetate 150 μg o.d. in comparison with placebo. Methods This was a randomised, double-blind, three-period crossover study (ClinicalTrials.gov identifier, NCT03257995) in patients with asthma on background ICS therapy. Patients with percent predicted pre-bronchodilator forced expiratory volume per second (FEV1) ≥50% and ≤ 90% were included in the study. Patients received indacaterol maleate 150 μg o.d., indacaterol acetate 150 μg o.d., or placebo on top of stable background ICS in randomised sequence. Trough FEV1 was assessed after 14 days of treatment. PK of indacaterol salts were assessed at steady state after 14 days of treatment; peak expiratory flow (PEF) rate and rescue medication use were collected with a combined PEF-meter/electronic diary throughout the study. Results Of the 54 adult patients (median age of 48 years), 51 patients completed the study. Both indacaterol salts demonstrated statistically significant improvements in trough FEV1 of 186 mL (maleate) and 146 mL (acetate) compared with placebo (both P < 0.001). FEV1 AUC0-4h improved by 248 mL (maleate) and 245 mL (acetate), and PEF by 33 L/min (maleate) and 30.8 L/min (acetate) versus placebo. Systemic exposure of indacaterol (AUC0-24h,ss and Cmax,ss on Day 14) was comparable after administration of both salt forms. Both salt forms demonstrated a good safety profile and were well tolerated, with a difference in the reporting frequency of AEs of coughing (maleate, 23.5%; acetate, 0%). Conclusions In patients with asthma, indacaterol maleate and acetate elicited comparable and significant improvements in lung function compared with placebo and achieved comparable systemic exposure. Both indacaterol salts were safe and well tolerated. Trial registration ClinicalTrials.gov NCT03257995 June 06, 2017

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The safety of indacaterol for the treatment of COPD

Cited by 8 publications

References 51 publications

Real-world Safety and Efficacy of Indacaterol Maleate in Patients with Chronic Obstructive Pulmonary Disease: Evidence from the Long-term Post-marketing Surveillance in Japan

Real-world Safety and Efficacy of Indacaterol Maleate in Patients with Chronic Obstructive Pulmonary Disease: Evidence from the Long-term Post-marketing Surveillance in Japan

Patient-reported outcomes and considerations in the management of COPD: focus on indacaterol/glycopyrronium bromide

Lung function, pharmacokinetics, and tolerability of inhaled indacaterol maleate and acetate in asthma patients

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